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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Smartgel — 6 UDI-DI variants, MDR (Orthos XXI, Unipessoal Lda)

MD Atlas
Orthos XXI, Unipessoal Lda

Data from EUDAMED, last updated May 31, 2026

Smartgel

56004569SMARTGEL7L

6 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: Orthos XXI, Unipessoal Lda

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 56004569SMARTGEL7L
Device name: Smartgel
Device model: Assento de Prevenção de Úlceras por Pressão
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: May 11, 2026

Manufacturer & authorised representative

Manufacturer

Name: Orthos XXI, Unipessoal Lda
SRN: PT-MF-000002787
Country: Portugal
Email: info@orthosxxi.com
Phone: +351253470270

Variants by status

UDI-DI variants

6 UDI-DI variants

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Applied filters

basicUdiUlid01KRB2A39EWVJZK03HAGQ2AK0C

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

63ASAEFL4305600456981448
63ASAEBL4505600456981431
63ASAEBL4305600456981424
63ASAETP4205600456981455
63ASAEBA4505600456981417
63ASAEBA4305600456981400